Evaluation of a new disposable "tampon like" electrostimulation technology (Pelviva®) for the treatment of urinary incontinence in women: A 12-week single blind randomized controlled trial

Aims To test the null hypothesis that a novel disposable “tampon like” electrostimulation device (Pelviva®) is no better than unsupervised pelvic floor muscle exercise for treatment of urinary incontinence in women. Methods Pre/post‐intervention assessor blinded, single center RCT. A total of 123 co...

Full description

Saved in:
Bibliographic Details
Published in:Neurourology and urodynamics 2013-06, Vol.32 (5), p.460-466
Main Authors: Oldham, Jackie, Herbert, Julia, McBride, Kathryn
Format: Article
Language:English
Subjects:
Adult
Disposable Equipment
Electric Stimulation Therapy - adverse effects
Electric Stimulation Therapy - instrumentation
electrostimulation device
England
Equipment Design
Female
Humans
Linear Models
Logistic Models
Middle Aged
Muscle Contraction
Patient Satisfaction
Pelvic Floor - physiopathology
pelvic floor muscle
Quality of Life
Recovery of Function
rehabilitation
Severity of Illness Index
Sexual Behavior
Single-Blind Method
Time Factors
Treatment Outcome
urinary incontinence
Urinary Incontinence, Stress - diagnosis
Urinary Incontinence, Stress - physiopathology
Urinary Incontinence, Stress - therapy
Urinary Incontinence, Urge - diagnosis
Urinary Incontinence, Urge - physiopathology
Urinary Incontinence, Urge - therapy
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Aims To test the null hypothesis that a novel disposable “tampon like” electrostimulation device (Pelviva®) is no better than unsupervised pelvic floor muscle exercise for treatment of urinary incontinence in women. Methods Pre/post‐intervention assessor blinded, single center RCT. A total of 123 community dwelling self referred women with symptoms of stress, urge, or mixed incontinence were randomly assigned to one of two 12‐week duration treatments: Pelviva® used for 30 min a day plus unsupervised pelvic floor muscle exercise or unsupervised exercises alone. Outcome measures included ICIQ‐UI (primary), ICIQ FLUTSex and global impression of severity and improvement (secondary) completed at recruitment, after 4 weeks of unsupervised exercise and immediately post‐treatment. Diary of exercise frequency/type, overall impression, and usage of device was completed mid‐ and post‐treatment. Results Pelviva® plus exercise produced significantly better outcome than unsupervised exercise alone: 5 points (45%) versus 1 point (10%) for ICIQ‐UI (P = 0.014); 67% versus 33% for leak frequency (P = 0.005); 40% versus 20% for leak interference with life (P = 0.018). Incontinence was less bothersome during sex to a greater extent in the Pelviva® group (P = 0.026). Women were enthusiastic about the device, found it comfortable/easy to use and experienced no adverse events. Conclusions The Pelviva® device plus unsupervised exercise is more successful than unsupervised pelvic floor muscle exercise alone in treating urinary incontinence. The device is easy/comfortable to use, there are no apparent adverse incidents, and women can manage their incontinence in the privacy of their own home. The product will be launched 2013. Neurourol. Urodynam. 32: 460–466, 2013. © 2012 Wiley Periodicals, Inc.
ISSN:0733-2467
1520-6777
DOI:10.1002/nau.22326